HemaTrate™ in the Treatment of Critical Limb Ischemia

Cook Research Incorporated2 enrolled

Overview

The primary objective of this study is to evaluate the performance of the HemaTrate™ Blood Filtration system in the treatment of critical limb ischemia. The primary endpoint measure is comparing the percentage of patients between the treatment arm and control arm who have freedom from major amputation, arterial intervention below the knee, and death through 12 months.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Critical Limb Ischemia Ischemia

Interventions

HemaTrate™ Blood Filtration systemDEVICE

Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.

SalineOTHER

Normal (0.9%) saline

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Critical Limb Ischemia in the study leg with ischemic rest pain and/or ulcer/minor tissue loss (Rutherford 4 or 5) 2. Previously failed an endovascular or surgical treatment of the study lower leg and is not being considered for additional intervention within the next 3 months OR is unsuitable for revascularization Exclusion Criteria: 1. Simultaneously participating in another investigational study (e.g., drug or device) 2. Pregnant or breastfeeding, or planning to become pregnant within the next 12 months 3. Major surgery (open cardiac, vascular, or abdominal procedure) within the past 90 days 4. Endovascular intervention within the past 30 days 5. Current dialysis, or expected to need dialysis within the next 12 months 6. Previous above the ankle amputation in the study leg

Locations (3)

Manchester Royal Infirmary, Manchester Vascular Centre

Manchester, Great Britian, United Kingdom

The Leeds Teaching Hospital NHS Trust

Leeds, West Yorkshire, United Kingdom

St Thomas' Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Freedom from vascular or endovascular arterial intervention below the knee of the study leg

Percent of patients that have vascular or endovascular arterial intervention reported below the knee of the study leg

Time frame: 12 months

Freedom from major amputation of the study leg

Percent of patients that have any amputation above the ankle of the study leg

Time frame: 12 months

Death

Percent of patients that exit due to death

Time frame: 12 months

Data from ClinicalTrials.gov

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